Biosimilars/General

American Academy of Ophthalmology biosimilars guidance details

Biosimilars/General | Posted 01/07/2022

The American Academy of Ophthalmology (AAO) recognizes the potential societal value of biosimilars for improving care of patients with eye disease.  Biosimilars should have sufficient research demonstrating their safety and effectiveness for treatment of eye disease. In January 2022, the AAO issued a policy statement on the biosimilars in ophthalmologic use [1].

Biosimilars approved in the US

Biosimilars/General | Posted 14/08/2015

Last update: 1 July 2022

In the US, a legal framework for approving biosimilars was established in 2009, via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

Biosimilars approved in Europe

Biosimilars/General | Posted 08/07/2011

Last update: 1 July 2022

In the European Union (EU), a legal framework for approving biosimilars was established in 2003. This framework means that biosimilars can only be approved centrally via the European Medicines Agency (EMA) and not nationally.

Current status of monoclonal antibody biosimilars approved in Latin America

Biosimilars/General | Posted 24/06/2022

By the end of 2021, biosimilar antibodies of rituximab, trastuzumab, infliximab, adalimumab and bevacizumab were expected to be commercialized in Latin America with 25 different brand names.

Overview of monoclonal antibody biosimilars in Latin America

Biosimilars/General | Posted 17/06/2022

This article describes the current situation of biosimilar monoclonal antibodies in 10 countries of Latin America and their potential to reduce the cost of antibody therapies.

American Academy of Ophthalmology biosimilars position statement published

Biosimilars/General | Posted 10/06/2022

The American Academy of Ophthalmology issued a policy statement on the use of biosimilars in ophthalmic practice in January 2022 [1].

US prescription drug expenditure projection report

Biosimilars/General | Posted 03/06/2022

United States expenditure on pharmaceuticals was up in 2021, finds a report published in American Journal of Health-System Pharmacy [1]. It also highlights that increased uptake of biosimilars is allowing for healthcare savings yet overall spending on drugs in the US will increase by up to 6% in 2022.

HHS new study on biosimilar use and expanded trials will include older patients

Biosimilars/General | Posted 29/04/2022

In March 2022, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) announced that it will launch a study on biosimilars use and spending trends in Medicare Part B. The US Food and Drug Administration (FDA) has also made changes to clinical trials to improve information available on use of biosimilars in older patients.

Needle-free delivery of biological drugs from Rani and Progenity

Biosimilars/General | Posted 22/04/2022

Rani Therapeutics and Progenity have announced the respective launch and development of new oral, needle-free methods to deliver large biological drug molecules.

British Columbia adds coverage for three new enoxaparin biosimilars

Biosimilars/General | Posted 15/04/2022

British Columbia, Canada has added PharmaCare coverage for three new enoxaparin biosimilars, a blood thinner used to prevent and treat blood clots.